PlainRecalls
FDA Devices Moderate Class II Ongoing

Spectral CT on Rails, Software Version 5.1.0, Model Number 728334

Reported: November 22, 2023 Initiated: October 9, 2023 #Z-0319-2024

Product Description

Spectral CT on Rails, Software Version 5.1.0, Model Number 728334

Reason for Recall

This recall is part of a 2-issue recall for the same system. When using the IVC needle position button, on the IVC control box during a series of scans, the plan box may not move to the desired needle position. This issue could result in the gantry moving to a location the operator does not expect. If this occurs, it presents a risk that the scan could occur at an incorrect location, or that the unintended motion of the gantry could cause a collision with the user or needle. The other part of the recall involves a software crash when the CCT foot pedal is activated (as described in RES ID93363).

Details

Recalling Firm
Philips North America
Units Affected
1 unit
Distribution
US Nationwide distribution in the state of MN.
Location
Cambridge, MA

Frequently Asked Questions

What product was recalled?
Spectral CT on Rails, Software Version 5.1.0, Model Number 728334. Recalled by Philips North America. Units affected: 1 unit.
Why was this product recalled?
This recall is part of a 2-issue recall for the same system. When using the IVC needle position button, on the IVC control box during a series of scans, the plan box may not move to the desired needle position. This issue could result in the gantry moving to a location the operator does not expect. If this occurs, it presents a risk that the scan could occur at an incorrect location, or that the unintended motion of the gantry could cause a collision with the user or needle. The other part of the recall involves a software crash when the CCT foot pedal is activated (as described in RES ID93363).
Which agency issued this recall?
This recall was issued by the FDA Devices on November 22, 2023. Severity: Moderate. Recall number: Z-0319-2024.